Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Migraine Disability Assessment
研究概览
简要总结
The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.
详细描述
This is a feasibility, non-randomized, non-blinded clinical trial enrolling patients who are at least 18 years of age for the treatment of chronic headache in the setting of Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement.
Patients are initially evaluated by a fellowship trained headache neurologist to obtain a detailed headache history, VAS score, MIDAS score, and physical examination. They are also evaluated by a neuro ophthalmologist with fundoscopic examination to assess for disc edema. A lab work-up is performed including complete blood count, basic metabolic panel, and microscopic urinalysis. A lumbar puncture and imaging work-up are then obtained as well.
Patients will proceed to an MRI to evaluate for Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus enhancement if they meet the following criteria:
- Daily headache from onset lasting > 3 months
- Headache described as pressure sensation
- Headache worsened in the Trendelenburg position
- MRI, MRA head and neck and MR venogram negative for possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc
a. Transverse sinus stenosis is allowed to proceed 5. Exposed to CSF pressure/volume lowering medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daily headache from onset lasting > 3 months.
- •Headache described as pressure sensation.
- •Headache worsened in the Trendelenburg position.
- •Exposed to CSF pressure/volume lowering medications.
- •Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.
- •Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.
- •MRI demonstrates that Nutcracker physiology is present.
- •Decreased SMA angle, renal vein narrowing, decreased AMD.
- •Retrograde lumbar vein flow and early EVP enhancement.
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Negative pregnancy test.
排除标准
- •Evidence of disc edema.
- •Positive urinalysis for hematuria or proteinuria.
- •Abnormal CBC or CMP.
- •MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.
结局指标
主要结局
Change in Migraine Disability Assessment
时间窗: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Measured by the Migraine Disability Assessment Test
Change in headache pain
时间窗: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Measured by a visual analogue scale (VAS) where 0 = no pain, 5= moderate pain, 10= worst pain
次要结局
- Adverse Events(1,3,7,14, and 28 days after the procedure and then monthly for 17 months)
- Serious Adverse Events(1,3,7,14, and 28 days after the procedure and then monthly for 17 months)
研究者
Zlatko Devcic
Principal Investigator
Mayo Clinic